Work

A review of the key issues associated with the commercialization of biobanks

Year: 2014

Type: article

Abstract: Biobanks1 have emerged as a significant research tool, gaining support from both the scientific community and regional, national and international research funding agencies. However, developing and maintaining these platforms is expensive. Indeed, in a recent survey of operational personnel representing 456 biobanks, funding shortages concerned 71% of those surveyed and 37% identified ‘funding’ as ‘the biobank's greatest challenge.’2 Thus, unsurprisingly, biobanks may seek support from the private sector or philanthropic organizations, which have an interest in sustaining them as research resources. The scientific community is also increasingly facing pressure to commercialize and translate their work, thus increasing expectations of industry partnerships.3 Funding agencies, in part, create and reinforce this commercialization pressure, by earmarking grants for projects that aim to bring products and therapies to the market within a short amount of time.4 This commercialization process creates a range of policy challenges for scientists, research participants, and funders. The goal of this document is to outline the policy issues associated with the commercialization of biobanks and, where possible, to review the relevant evidence and/or ethical and legal norms.5 We do not attempt to provide suggestions for policy reform. Nevertheless, given that securing funding for biobanks remains a challenge and that researchers are increasingly pressured to work with industry and to rapidly translate their work, a scoping document of this nature—one that draws together international expertise and relevant research—seems timely and, we hope, can stand as a resource for future research and policy work. ‘Commercialization’ can refer to a number of different activities. It can refer to the commercialization of biobank resources (data or samples of human biological material) or of research results derived or products developed from those resources. It can also refer to publicly funded biobanks partnering with or receiving funding from private, for-profit entities like biotech companies, pharmaceutical corporations, or the medical device industry. For the purposes of this scoping document, we will largely focus on the introduction of private funding and partnerships to an existing, publicly funded biobank. This focus is justified because many biobanks are not-for-profit entities associated with larger (often publicly-funded) bodies, such as universities and hospitals, and funded, often through short-term grants, by these bodies, by the government, or by a mixture of public and private funds.6 Survey evidence indicates that these biobanks are greatly concerned with securing adequate long-term funding.7 As Meijer and colleagues note, with the expansion and change in the size, goals and structure of biobanks, ‘stable sources of core funding will be necessary in most cases, from the public sector, patient organizations and private foundations.’8 Given this reality, we believe that commercialization will particularly and uniquely impact publicly supported biobanks, as they consider various means, including private partnerships, to ensure financial security.9 Of course, biobanks vary greatly in organization, priorities, and funding,10 and thus commercialization will affect different biobanks in different ways. Not every biobank will seek commercial partnerships in response to financial pressures, and, indeed, delineating which factors (eg type of biobank; organizational structure; research goals and focus) influence the development of private partnerships may be an important question for future research. Indeed, we hope this overview of issues will inform these future funding decisions. In addition to our primary focus on the introduction of private financing and partnerships, some of the emerging research and commentaries on the issues associated with commercialization are relevant to a range of other activities and are worth considering here. For example, issues of public trust can be triggered by a variety of commercialization practices, as we will see. Thus, where appropriate, we will discuss commercialization activities beyond just the introduction of private funding. Before turning to the issues at hand, it may be useful to set out some of the scenarios in which commercialization may occur. In this paper, as noted, we largely concentrate on the introduction of private funding to a pre-existing publicly funded biobank. In such a case, a chief concern for the biobank will be retaining participants who were, presumably, originally recruited with an understanding that the biobank would be a ‘public good.’ In this case, issues related to consent, participant retention, and withdrawal of biological material and associated data are particularly important. We can contrast this with a scenario in which the biobank is a public-private partnership from its inception. In such as case, enrollment of participants and obtaining consent to commercial imperatives, if any, are likely to be the prime focuses of the biobank. The different situations of these biobanks may inform and nuance the discussion that follows. Trust is critical in determining whether people will participate in and support biobanking research. Public trust and how it influences the public's support for science is complex and influenced by many factors, including perceptions of the actors and institutions involved in research.11 There is little doubt that the general public places a good deal of trust in the university-based scientific community. For example, a 2013 survey of United Kingdom residents commissioned by the Wellcome Trust found that 66% percent of respondents completely trusted or had a great deal of trust in university scientists.12 However, it also showed that trust evaporated quickly if scientists worked for either industry (trusted by 32% of respondents) or government (trusted by 34% of respondents).13 This has also been the case in Australia, where the Swinburne National Technology and Society Monitor has consistently found high public trust in scientists, universities and government research organizations.14 Trust in public research institutions remains high even for controversial medical research (including some research in genetics), but decreases significantly with industry involvement.15 The involvement of industry in research seems to have considerable influence on public trust in science, irrespective of the type of research.16 This holds true in the biobanking context, as well. Several studies show that many participants have a negative attitude towards the involvement of commercial entities in biobanks and biobanking research.17 A survey of 1,201 Albertans found that public trust in biobanking research decreases substantially if industry is involved: 45.1% of those surveyed indicated they had ‘a great deal’ of trust in university-funded scientists; 19.5% had ‘a great deal’ of trust in university scientists funded by industry; and only 6% had similar trust in biobanking research conducted by for-profit industry.18 A recent public opinion study of cancer patients similarly showed that 40.4% of participants reported having ‘a great deal’ of trust in biobanking research performed by government-funded university researchers as opposed to 16.3% and 3.2% of respondents reporting ‘a great deal’ of trust in industry-funded university research and research conducted by industry, respectively.19 Interestingly, a study by Critchley and Nicol suggests that the type of organization (eg private entity versus university) has a greater impact on public trust than funding source (eg private versus public funding), though the source of funding also influences public trust.20 Though their study was not specific to biobanking research, it may suggest that public biobanks which receive private funding will be better able to maintain public trust than those that are completely privately owned. Many factors may account for a negative view of private investment in public biobanks. For instance, there is some evidence that members of the public fear that their donated biological samples and associated health data will be used in ways they find morally problematic, such as in research that may be stigmatizing or discriminatory to them and/or their communities21 (for example, research connecting mental health with racial or ethnic background). Some biobank participants fear losing control over how their samples and data are used and with whom they are shared, and this fear may be heightened when for-profit companies invest in publicly funded biobanks. This notion is manifested in recent research by Critchley, Nicol, Otlowski and Chalmers (unpublished manuscript), which found that concern about sharing of genetic data with private entities was the chief reason for the significant erosion of support when genetic tests were conducted by a private company compared to those controlled by the public health care system.22 The public generally supports biobanking research,23 though the terms on which people will participate and the expectations they have regarding participation are not uniform and differ on key matters like benefit sharing.24 Some people participate for altruistic reasons, without expecting any benefits in return.25 Other people are more likely to participate in biobanking research if they believe that biobanks will produce beneficial results for future patients and society.26 Some participants do expect to receive something in return, including monetary reward, reduced costs of the (potential) clinical benefits derived from biobanking research, or the return of research results.27 These observations also seem connected with the idea that private interests, including the introduction of industry funding, may limit sharing of biological material and associated data, prevent results from being returned, or limit public access to health benefits derived from private or proprietary research. The belief that public access to benefits will be reduced has been found to be an important reason for the decrease in public support for industry-based medical research (relative to publicly funded researchers).28 This finding, combined with the public's desire for biobanks to share results and advance health care, suggests that some sort of benefit sharing arrangement or return of benefits back to the community may help the public accept the commercialization imperative.29 Involvement of commercial entities, in the form of financial support for public biobanks, thus has the potential to change the motivations and expectations of the general public, hence altering the relationship between participants and biobanks. Of course, the particular way in which financial support from industry will affect this relationship and related motivations and expectations depends on many factors and may differ between distinct groups within the public. The hype from genomics generally redounds to biobanks and this too might impact public expectations, such as the belief that biobanks will result in benefits in the near future.30 If the benefits of biobanking are seen to be oversold, the involvement of commercial entities in the form of financial support is likely to garner even greater suspicion.31 The expectation that public investment should yield results for the public good can be used to justify the creation of publicly funded biobanks and also the adoption of a range of biobanking policies that may be ethically or legally contentious (eg the use of a general or broad consent approach).32 The involvement of industry can create questions about the degree to which the biobank research is being done solely—or even primarily—for the public good, thus compromising, in the eyes of the public, the validity of the justification for the adoption of these policies. It seems reasonable to think that if the public perceives scientists from private research organizations to be more self-interested (ie for profit) than interested in the public good, this could diminish trust in biobanks that previously involved only publicly funded scientists, and thus hinder public participation. Yet this simple calculus has several limits. First, a sweeping statement that all public institutions are more trustworthy and private ones have motives contrary to the public good is a glaring oversimplification. Although we have referred to research which suggests that government-funded scientists are perceived to be more trustworthy than those working in private industry, there is an underlying distrust of the government as an overseer of biobanking practices.33 Second, trust in actors and institutions differs between various groups and may be influenced by factors such as race, gender, education, political or other ideology, religion, geography, and whether the individuals in question are impacted by a disease.34 However, some evidence suggests that demographic factors have little impact on biobanking preferences and should not be viewed as determinative of peoples’ biobanking preferences.35 Third, not everyone will reject participating in a biobank that has some commercial elements. Studies suggest that patient groups tend to be more accepting of pharmaceutical involvement than other civic groups, for example, and participants may be more at ease with commercialization elements if it means the biobank is ‘governed or regulated’ appropriately.36 Additionally, not all ‘private’ actors are seen identically and not all ‘public’ sources are deemed trustworthy. The actual governance and operations of the biobank, whether it is partly or privately (ie or publicly (ie government, or funded, and the and goals of the biobank likely influence perceptions of Although considerable have been to the of the general public, and other groups, and their to participate in biobanking more research is as it to the involvement of commercial entities in in the form of financial support or access by scientists to biobank research could focus on determining the perceived of commercial involvement in biobanking that affect public trust (eg losing control over of biological samples and data, access to the benefits of research, the return of and and research and may about biobanking and commercialization and desire to receive If public and are will this to greater of commercial involvement in if which will the general public accept various of commercial involvement in publicly funded research could also whether and how the introduction of private funding or partnerships the of and preferences that an about whether to participate in biobanking how public trust is by different commercialization practices, future can focus on the related of how to or trust in public biobanks that with private It may for example, that to public-private as for benefit by private as about and goals and the erosion of public trust that may The of on many key biobanking combined with public to recent relevant to in a different (eg versus of of samples by of should that trust can and may have a impact on biobanking may result in between the of private and those of the researchers or of the biobank, which a number of If commercial entities funding for biobanking research, scientists of their over the development of the private investment or the of commercial may other or For example, a biobank might of data or samples that either of the resource or are with the consent of participants in to private funding. scientists may research with commercialization in the form of financial between private entities and university scientists could research For example, studies in other of research have that research to Public of science as a for the ‘public may be impacted by these As might work contrary to the of to public health both by some research and by the research and our understanding as to an important health The of consent has to be of the most in the of biobanking research. and research not publicly funded these the of the consent and may to of biobanking issues in with the commercialization of products and therapies derived from research on biobank samples and consent and that researchers inform participants about potential commercial of their biological samples and consent issues also when considering the introduction of financial support by private entities to public biobanks, particularly if this had not been in the The of research participants about potential commercial from research on their samples and of industry been by and is in part, because of potential commercial has been to be a relevant in the of individuals to participate in research. 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Source: Journal of Law and the Biosciences

DOI: 10.1093/jlb/lst004